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Johnson & Johnson ($JNJ) and Bayer AG are looking on the bright side of things when it comes to Xarelto. They are undertaking new trials they hope will lead to much wider use of the new kind of blood thinner. The announcement comes days after the FDA for the second time rebuffed their bid to get it a coveted approval for treatment of acute coronary syndrome (ACS).

Bayer said the companies will test the pill in a Phase III trial on patients with chronic heart failure and significant coronary artery disease. They said it is the first of the new anticoagulants to be evaluated for this patient group and point out that heart failure is a big problem worldwide. J&J's Janssen Research & Development outlined 5 trials being undertaken. 

The drug is already approved for 6 uses, but the FDA has now twice refused to give the drugmakers approval for treatment of ACS, an indication the partners badly want because there are 1.2 million ACS patients sent to the hospital each year. The FDA initially asked for more data, including on bleeding risks, but this week said that what it was given still fell short of what it needs to allay concerns. J&J said Monday it was evaluating what the FDA had to say.

Xarelto is one of several drugs that have came on the market to challenge warfarin, which has been the standard treatment for years but which comes with its own troubling side effects. Pradaxa from Boehringer Ingelheim was the first warfarin alternative to market and is now used by millions of patients globally.

Bayer and J&J have big expectations for Xarelto. In a recent R&D update, Bayer CEO Marijn Dekkers touted his estimates for Xarelto once again, saying Bayer could realize $2.5 billion in annual sales from the drug. But bleeding risks continue to hold back the potential for the new drugs because, unlike warfarin, there is no antidote for that. Last month, Bayer and J&J said they had teamed up with Portola Pharmaceuticals to test PRT4445, an agent that may be able to counteract heavy bleeding. If it works, doctors wary of the warfarin alternatives would be more likely to choose Xarelto over warfarin. Boehringer is working to identify its own antidote for Pradaxa, a thrombin inhibitor, and points out that instances of severe bleeding in Pradaxa patients are still less common than in warfarin patients.

- here's the Bayer release
- here's the Janssen release
- more from Reuters

Related Articles:
Bayer, J&J's Xarelto again falls short in bid for ACS use
Fight for anticoagulant market heats up with antidote deals
Europe adds new uses to Xarelto's marketing arsenal

Editor's note: The story was updated to make clear that the antidote being developed by Portola Pharamaceuticals is only for Factor Xa inhibitors.

And so, the curtain is about to come down on another working week, although the curtain is made of snow. Despite hopes that spring is near, mounds of snowflakes are blanketing the Pharmalot corporate campus. Just the same, this will not dampen our modest weekend plans, which call for naps, reading and people watching. What about you? Anything special planned? Those of you in warm environs may want to get a jump on spring cleaning or you could file those taxes, since Uncle Sam needs help now that the sequester is reality. Or you could simply do nothing. Whatever you choose, have a grand time, but be safe. See you soon…

Bayer Eyes Wider Use For Xarelto (Reuters)

Mouse Study Reveals Why Some Cancer Vaccines Fail (NPR)

Europe Unveils New Symbol For Monitoring Medicines (Pharma Times)

Alzheimer’s Seen Scan Decades Before Dementia: Study (Bloomberg News)

FDA Approves Roche Hepatitis C Test (MedPage Today)

Authors Retract Two Remicade Papers After Legal Battles (Retraction Watch)

India To Speed Ethics And Side Effect Reviews For Trials (Outsourcing Pharma)

Six Months Later, Fungal Meningitis Outbreak Lingers (NBC)

FDA Lawyer Rick Blumberg Passes Away (Regulatory Focus)

EDITOR’S NOTE: Please check this post for additional items during the day

snowman pic thx to mealymonster on flickr

Persistence may be a virtue, but it doesn't always pay. Johnson & Johnson ($JNJ) and Bayer tried again to persuade FDA on a new use for Xarelto, in patients with acute coronary syndrome (ACS). But once again, the attempt failed.

It's a blow for Xarelto, which so far has racked up 6 indications in the U.S. One of those addresses a big market–patients with atrial fibrillation–but the ACS population could have been even bigger. Some 1.2 million ACS patients are hospitalized each year. J&J and Bayer jointly developed the drug, and J&J has U.S. marketing rights.

FDA turned away J&J's first request for the new indication last June, citing some missing data on 1,000 trial participants who had pulled out. The agency was also concerned about the drug's bleeding risks. Janssen, the J&J prescription-drug development unit, came back with additional data, but that wasn't enough to sway the FDA.

Xarelto is one of the new generation of drugs challenging the standard anticoagulant warfarin. It came to market second, on the heels of Boehringer Ingelheim's Pradaxa. It's the only one of the three that had generated strong enough data in ACS patients to warrant an application for the indication. Pfizer ($PFE) and Bristol-Myers Squibb's ($BMY) new entry, Eliquis–which arguably has the best data of the three, overall–failed in an ACS trial. Currently, the clot-fighting drugs FDA-approved for that use are AstraZeneca's ($AZN) Brilinta and Eli Lilly's ($LLY) Effient, along with the Sanofi ($SNY)/Bristol-Myers drug Plavix, which is now off-patent.

- see the Reuters story
- get more from Bloomberg

Related Articles:
Fight for anticoagulant market heats up with antidote deals
Europe adds new uses to Xarelto's marketing arsenal
Bayer gambling $4B R&D budget on Xarelto, top blockbuster hopefuls
J&J's Xarelto nabs new clot-prevention use

Rise and shine. Another busy day is on the way. Once again, we are scurrying about here on the Pharmalot corporate campus, where the sun is shining, the official mascots are making too much noise and we are deposting assorted short people at various schoolhouses. Not only that, we are preparing for another round of reading documents and scheduling meetings. We trust you can relate. So grab a cup of stimulation, because there is no time to waste. Have a great day and stay in touch…

Pfizer Gets Celebrex Patent Extention And Sues Generic Makers (Reuters)

FDA Rejects Xarelto Bloodthinner For ACS, Again (MedPage Today)

Roche Chairman Franz Humer To Retire Next Year (Bloomberg News)

White House Urges Congress To Let FDA Spend User Fees (Pharma Times)

Australian Court Invalidates Three AstraZeneca Crestor Patents (Dow Jones)

HIV Drugs Spurned By African Women In Prevention Study (Bloomberg News)

FDA Panel Nixes Two Hot Flash Drugs (MedPage Today)

EDITOR’S NOTE: Please check this post for additional items during the day

Bayer chief Marijn Dekkers–Courtesy of Bayer

Bayer's new drugs are bringing home the bacon. The German drugmaker raised its 2015 forecast for 5 key products to €2.5 billion ($3.3 billion)–and confirmed previous promises that those drugs would surpass €5.5 billion by 2020.

Already, those drugs helped push Bayer HealthCare's 2012 sales up by 8.4% to €18.6 billion, or about $24.38 billion. The anticoagulant Xarelto alone grew 265%, to €322 million, as it was launched in new markets around the world. And those key products are expected to drive 6% annual sales growth for the unit through 2015. "The fact that almost half of peak sales could be reached in three years already is remarkable," Bankhaus Metzler analyst Sebastian Frericks told Reuters.

The company also turned in strong emerging markets growth–pharma sales alone jumped by almost 8% there, compared with mostly stagnant sales in Europe. Emerging markets now account for around 37% of the entire company's sales.

The growth predictions are a standout in the pharma industry these days. Most Big Pharmas forecast flat sales growth for this year as they continue to struggle with patent cliff losses. And 2012 growth for most was anemic at best. Bayer figures on "mid-single-digit sales growth" from HealthCare for 2013, to about €19 billion.

- see the statement from Bayer
- get more from Reuters

Special Report: The 15 best-selling drugs of 2012

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Xarelto does not have a quick-acting antidote to heavy bleeding.–Courtesy of Bayer

What would top Xarelto for Bayer and Johnson & Johnson? Xarelto with an easy antidote. The anticoagulant, one of a handful of new alternatives to the difficult-to-administer warfarin, comes with a risk of bleeding. So does warfarin. But warfarin has a quick-acting antidote. Xarelto and its new peers do not.

Yet, that is. Bayer and J&J ($JNJ) have teamed up with Portola Pharmaceuticals to test PRT4445, an agent that may be able to counteract heavy bleeding. If it proves itself, then doctors wary of the warfarin alternatives would be more likely to choose Xarelto over warfarin.

They might also select Xarelto over Pradaxa, the first warfarin alternative to market. Sold by Boehringer Ingelheim, and now used by millions of patients globally, Pradaxa has been blamed for more than 1,000 deaths. Some high-profile cases have scared off doctors who might dislike the cumbersome warfarin, but prefer a ready-to-hand antidote in case of emergency. Boehringer is working to identify its own antidote for Pradaxa, a thrombin inhibitor, and points out that instances of severe bleeding in Pradaxa patients are still less common than in warfarin patients.

The battle for share in the warfarin-alternative market is important for all 5 companies. Each is expecting big sales from their respective products; Bayer, for one, has pegged Xarelto as a $2.5 billion-a-year product.

Unfortunately for Bayer and J&J, an antidote to Xa factor inhibitors would also work in bleeding emergencies triggered by Eliquis, a competing Xa drug from Pfizer ($PFE) and Bristol-Myers Squibb ($BMY). And those companies have their own deal with Portola.

Already sold in the U.S. and E.U. for certain types of blood clots, Eliquis only recently won approval to prevent stroke in patients with atrial fibrillation. Its supporting data on the efficacy side is considered stronger than Xarelto's. So, while an antidote may give Xarelto an edge over warfarin or even Pradaxa, it still may lose out in the balance against Eliquis.

- see the release from J&J
- read the MedPage Today story

Related Articles:
Clot-fighter Eliquis wins speedy new backing from NICE
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Clot-fighter Eliquis won a thumbs up for stroke prevention–courtesy of Pfizer

The U.K.'s cost-effectiveness watchdogs must really like Eliquis. The new blood thinner from Pfizer ($PFE) and Bristol-Myers Squibb ($BMY) won a thumbs-up for stroke prevention, just three months after winning approval for that use in the E.U. It's a nice push forward for the drug, which will be vying for market share against Bayer's Xarelto and Boehringer Ingelheim's Pradaxa.

The National Institute for Health and Clinical Excellence issued final draft guidance backing Eliquis to prevent strokes in patients with atrial fibrillation, an abnormal heart rhythm. The drug was already approved to prevent and treat venous thromboembolism, but the stroke-prevention use is the real prize. It's a much larger market.

Eliquis may be third to reach the market after Pradaxa and Xarelto, but it's been hotly anticipated as clearly superior to warfarin. NICE's Carole Longson said the agency's appraisal committee concluded that Eliquis was "more clinically effective than warfarin" at reducing stroke and systemic embolism, and that the drug "resulted in fewer bleeding events than warfarin," including dangerous bleeding in the skull.

The old standard treatment comes with a host of dosage-tweaking rules, plus interactions with alcohol and food, so it is difficult for patients to take and doctors to manage. Longson cited those difficulties in announcing the Eliquis approval: "The Appraisal Committee heard from patient experts that warfarin can have a greater impact on a person's quality of life than atrial fibrillation itself," she said.

The advent of Eliquis will put Boehringer and Bayer on their toes. The first-to-market Pradaxa now comes with safety warnings, including a caution against its use in people with kidney problems. Worries about bleeding risks have put some doctors off its use, despite the fact that it's seen as no more dangerous than warfarin, because the new-generation anticoagulants don't have quick-acting antidotes as the old drug does. Xarelto won't escape the Eliquis launch unscathed, either, analysts have said.

- get the release from NICE
- read the PharmaTimes story

Special Report: Eliquis – Blockbuster buzz: 15 top therapies in late-stage development

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Rack up another set of new uses for Bayer's Xarelto. The anticoagulant won European approval to treat and prevent pulmonary embolism and to prevent deep vein thrombosis. It's the first warfarin-alternative drug to win these indications, giving it an edge over its rival Pradaxa.

The European clearance follows a similar expansion of Xarelto's market in the U.S., where it's marketed by Bayer's development partner Johnson & Johnson ($JNJ). Early this month, FDA approved Xarelto to treat PE and DVT, and to prevent a recurrence after initial treatment. Both the EMA and FDA have cleared the drug to prevent clots in certain surgery patients and to reduce the risk of stroke in patients with atrial fibrillation.

It's all part of Bayer's plan to pump Xarelto into a major blockbuster. In a recent R&D update, CEO Marijn Dekkers touted his estimates for Xarelto once again, saying Bayer could realize $2.5 billion in annual sales from the drug.

The company also announced plans for a major outcomes study, which will pair Xarelto with aspirin. The aim is to determine whether the regimen will prevent stroke, heart attack and death in patients with coronary and peripheral artery disease.

It hasn't been all smooth sailing for the drug, however. Earlier this year, the FDA dealt a big disappointment to J&J and Bayer's hopes; it declined to approve it to prevent heart attacks and other cardiovascular events in patients with acute coronary syndrome. J&J has submitted new information to the agency, expecting a response early next year.

- see the release from Bayer
- read the RTT News story
- get more from PM Live

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Pradaxa, Xarelto gain reprieve as FDA delays Eliquis decision

Top of the morning to you. Gray skies may be hovering over the Pharmalot corporate campus today, but our spirits remain sunny as we recall a favorite expression from the indubitable Morning Mayor, who often opined that “every brand new day should be unwrapped like a precious gift.” So while you tug on the proverbial ribbon, please join us for a cup of delicious stimulation – Pumpkin Spice is on the way – and take a look at some interesting items. Have a great day and drop us a line if you hear something juicy…

Bayer To Study Xarelto For Heart Attack Prevention (Reuters)

Mercks End Development Of Diabetes-Cholesterol Combo Pill (Dow Jones)

J&J Isn’t Giving Up On Bapi Alzheimer Drug (Bloomberg News)

Least-Experienced Docs Are Highest Spenders: Study (Pharma Times)

A Merck Drug For Worms May Control Bed Bugs (Bloomberg News)

Nektar Stock Falls Over Risk Of Opioid Constipation Drug (MedCity News)

Croatia Arrests Pharma Execs And Docs On Bribery Charges (Associated Press)

Italy Arrests Several Cardiologists In Fraud Probe (CardioBrief)

Pakistan Ratifies Bill Creating Regulatory Authority (Express Tribune)

EDITOR’S NOTE: Please check thist post for updates

Johnson & Johnson ($JNJ) and Bayer's blockbuster candidate Xarelto just won access to a new market–one that could eventually account for about $600 million in sales. It's just the latest in a series of indications added to the clot fighter's label.

Already FDA-approved for stroke prevention in patients with atrial fibrillation, as well as clot prevention in certain surgery patients, the drug can now be marketed to treat and prevent clots in the legs and lungs. Xarelto is one in a new generation of anticoagulants, designed to be alternatives to the old standard, warfarin.

The FDA's backing is a victory for Xarelto, which lost out in June on a big new indication. The agency declined to approve it as a preventive in patients with acute coronary syndrome, a potentially enormous market. J&J recently submitted new data and is looking for a response early next year.

If Xarelto performs as J&J and Bayer hope, it will be a multibillion-dollar seller for both companies. In this latest group of patients, it has the potential to change the standard of care, one researcher said. "Venous blood clots are associated with a high risk of serious complications, so the approval of Xarelto will immediately impact how we treat these patients," New York University School of Medicine Professor Jack Ansell said in a J&J statement.

FDA announced the new indication on the same day as news about Xarelto's head-to-head rival, Pradaxa. That drug, sold by Boehringer Ingelheim, has been under review for safety, after patients using it experienced serious bleeding and hundreds died. FDA concluded that rates of bleeding were no greater in Pradaxa patients than in warfarin patients.

- get the FDA release
- see the J&J announcement
- see the Bloomberg story

Related Articles:
Bayer CEO touts Xarelto in Q3 pharma-sales growth
J&J, Bayer try to answer FDA concerns on Xarelto
FDA panel draws blood in Xarelto's bid for new use
Bayer gets positive ruling from NICE on Xarelto
Bayer's Xarelto could gain edge from new ACS trial